TELADOC BLOOD PRESSURE MONITOR
Received Jul 7, 2026 · Event occurred Jun 12, 2026
Report 3011196194-2026-00049 · MDR key 25732387
Device
Generic name
Blood Pressure Monitor
Manufacturer
Teladoc Health IncModel number
HT900Catalog number
OFG06546
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
56 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE PAITENT REPORTED INACCURATE READINGS FROM THEIR TELDOC BLOOD PRESSURE MONITOR. THE TELADOC MONITOR READINGS WERE APPROXIMATELY 20 POINTS HIGHER WHEN COMPARED TO READINGS OBTAINED USING THE DOCTOR'S MANUAL PUMP MONITOR. THE MEASUREMENTS WERE TAKEN 1-3 MINUTES APART. NO MEDICAL TREATMENT WAS REPORTED IN CONNECTION WITH THE DEVICE MALFUNCTION.
Additional Manufacturer Narrative
THE DEVICE RELATED TO THIS INCIDENT WAS RETURNED FOR INVESTIGATION. INTERNAL FUNCTIONAL TESTING WAS PERFORMED, AND NO FAILURES WERE DETECTED DURING FUNCTIONAL TESTING. THE INTERNAL INVESTIGATION CONFIRMED THE DEVICE WAS WORKING AS INTENDED.
Remedial action
- Replace